Legal Considerations

Overview
Many individuals or organizations considering early defibrillation program implementation have questions regarding federal and/or state regulations, and whether or not there exist any liability risks. The liability risks associated with owning or operating an automated external defibrillator (AED) are generally quite small for lay responders. AEDs when coupled with appropriate training have been proven to be extremely safe, reliable, and effective at saving lives that would have otherwise been lost.

Wide Acceptance, Possible Reverse Liability
Many states now encourage or mandate placement of AEDs in some locations such as schools and health clubs. Their use has become so commonplace, that certain types of organizations have been sued for not having AEDs -- a trend many experts expect to see continue, as organizations increasingly find that the risk of having AEDs is generally much lower that not having them.

"Do No Harm"
One cornerstone of the legal argument for AEDs is that they "do no harm". Modern AEDs are very specific for cardiac arrest heart rhythms, and only permit shocks to be delivered to victims that truly need them. It is not possible to deliver a shock to someone who is not in cardiac arrest, or harm a person. A victim in cardiac arrest is in urgent need of a defibrillator and will otherwise certainly die. It is really not possible to "harm" such a person or make them worse off. Use of an AED can only help.

"Good Samaritan" Laws
Federal and state "Good Samaritan" laws have been established to provide immunity from certain civil liability actions due to the emergency use of defibrillators. An example is the Cardiac Arrest Survival Act of 2000.

Manufacturer Indemnification
Better AED manufacturers, such as Philips Medical Systems, provide an additional level of protection by offering limited indemnity to users of their AEDs. Click here to see Philips Medical Systems indemnification.

Medical Oversight
All automated external defibrillators, and some accessories, are classified by the FDA as prescription devices, and physician authorization is required for purchase. In addition to this requirement, many states require ongoing medical (physician) oversight for the operation of a defibrillation program. Having an individual physician or organization oversee the implementation an operation of a defibrillation program is always a good idea.

Further Information
Additional discussion of the legal issues surrounding early defibrillation program implementation written by Richard Lazar, Esq., a legal expert on emergency medical services topics, can be found at the National Center For Early Defibrillation.

The information above is provided as general information and should not be considered legal guidance, nor a substitute for the advice of a qualified attorney.

 

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